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PubMed2003

The Magdeburg Clinical Studies' Network for pediatric diseases.

New pharmaceutical technologies had created either enthusiastic hope for major improvements in the medical treatment or major doubts on the use of research data and wrongdoing in clinical trials. Clinical investigators have to consider methodological and scientific principles, to stick to ethical rules, national law and international guidelines. With the invention of General Clinical Research Centres the necessary infrastructure in hospitals with well-trained personnel and the availability of laboratory, clinical and supporting service has been created in the US. Taking GCRC as a model to improve the clinical research in pediatrics, a formal collaboration between the Department of Pediatrics and the Institute for Biometry and Medical Informatics was established at the Otto-von-Guericke-University Magdeburg in 2001. Both nation-wide quality assurance programmes in Pediatric Endocrinology and clinical trials according to the principles of good clinical practice ('GCP') were planned and currently performed. Thus with the resources of the Medical faculty and additional project bound finances the necessary infrastructure has been developed.

Clinical Trials as Topic↗
PubMed2004

Interactions between emergency medicine programs and the pharmaceutical industry.

OBJECTIVES: To examine the beliefs and practices of emergency medicine program directors regarding interactions with the pharmaceutical industry. The authors also sought to study the prevalence of program policies and the desire for organizational policies. METHODS: The Board of the Council of Emergency Medicine Residency Directors (CORD) requested and approved a member survey. An institutional review board-approved, Web-based, 30-item survey was sent to all CORD members subscribed to the organization's listserv in May 2002 and was completed by June 2002. Program director respondents were surveyed as to their beliefs and practices regarding industry sponsorship of speakers, social events, drug samples, travel to conferences, and the educational value of marketing representatives. Subjects were queried about their awareness of existing guidelines and whether they desired policy development by CORD. RESULTS: Surveys were returned from 106 programs (85%). The majority of program directors (72%) "never" or "very rarely" allowed unrestricted interactions between pharmaceutical representatives and residents at work. However, only 52% of program directors said they "never" or "very rarely" allowed pharmaceutical representatives to give residents free drug samples at work. Only 46% said they "never" or "very rarely" allowed pharmaceutical representatives to teach residents. Two thirds of program directors desired CORD guidelines regarding interactions with the pharmaceutical industry. Program directors seeking guidelines were less likely to allow pharmaceutical representatives to teach residents (p = 0.001). They were also less likely to allow pharmaceutical representatives unrestricted interactions with residents (p = 0.05). CONCLUSIONS: A wide range of practices exist among emergency medicine residency program directors, and most desire organizational guidelines regarding interactions with the pharmaceutical industry.

Attitude of Health Personnel↗
PubMed2003

[Documents for clinical trials of new drugs: results of their reviews prior to submissions to IRB].

A prior review process was introduced in the Institutional Review Board (IRB) of the University of Tokyo Hospital to facilitate the evaluation of clinical trial plans for new drugs. This study summarizes the results of prior reviews of 73 protocols that were submitted to the IRB during 1999-2000. A total of 955 items were taken up for discussion at the prior review. Among them, 325 (34.0%) were related to the profile/description of investigational drugs themselves, and 252 (26.4%) were related to the trial plan. Major requests related to investigational drugs and given to applicants after the prior review were on adverse reactions, pharmacodynamics, and pharmacokinetics. Items related to patient selection criteria and usage of concomitant drugs were major requests related to the protocol. In some cases, protocols were amended by applications in accordance with the requests. The study shows that the review of new drug clinical trial plans prior to the evaluation by the IRB and examination from a pharmaceutical viewpoint are meaningful and worthwhile.

Clinical Trials Data Monitoring Committees↗